Summary
Supervisa la planificación, ejecución e interpretación de la investigación de ensayos clínicos, las actividades de recopilación de datos y las operaciones clínicas. Establece y aprueba métodos científicos para el diseño e implementación de protocolos clínicos, sistemas de recolección de datos e informes finales. Apoyar la investigación clínica y los ensayos clínicos nuevos y en curso y garantizar el procesamiento eficiente y oportuno de los acuerdos de confidencialidad y los acuerdos clínicos. Monitorea el cumplimiento de los protocolos y determina la finalización del estudio. Gestiona archivos clínicos y regulatorios y mantiene el inventario clínico destinado a su distribución a sitios de investigación
About the Role
Major Accountabilities Functional Excellence Accountable for CRMAs to deliver high quality clinical/medical program and trial feasibility for GDD and NIBR PoC trials; drives country clinical/medical feasibility process and outcome improvement including identification of new investigators and medical experts. Accountable for co-ordinating cross-CPO/Cluster initiatives to support recruitment for GDD studies, liaising between the CRMAs and the global team. Leverages innovation in clinical trial planning and execution, including patient engagement as appropriate to deliver recruitment goals. Supports CD&A vision to develop innovative clinical development plans that change the world by sharing early insights from sites, regional/local guidelines, patients and payers in partnership with medical affairs and the local Trial Monitoring Organization. Provides Clinical Development leadership to develop and execute innovative, patient-friendly and competitive clinical trial concept sheets/protocols by supporting nomination of experienced CRMAs to GCTs and other global/regional working groups and ensures high quality feedback. Performs CRMA activities as needed to cover potential CRMA resource gaps and may represent the clinical/medical and scientific interests in internal and external forums to support GDD and NIBR trials In collaboration with the local Trial Monitoring organization accountable for adherence to safety standards, clinical data quality and regulatory legislation. Ensures Cluster delivery by identifying and developing new sites, builds competitive advantage to establish Novartis as a preferred clinical research partner. Is accountable to implement global clinical standards for CRMAs. May coach the development of local study protocols, implementation and analysis, especially for local studies requested by Has. Guide CRMAs on how to ensure a smooth transition and collaboration with Medical Affairs (e.g. transparency of activities, availability of new data etc.). Stakeholder Management Drives trial site performance and providing superior customer experience for investigators / site study teams, significantly impacting the external visibility and reputation of Novartis. Uses advanced influencing skills to manage collaborations between Cluster/local GDD, Medical Affairs and Patient Access, balancing potentially diverging objectives to achieve superior results. Aligns Cluster with Regional objectives. People Hires CRMAs in the Cluster in collaboration with the Regional CRMA Head, the CSO in the country the CRMA will be hired (or delegate) and the country Trial Monitoring Organization. Accountable to implement global clinical standards for CRMAs incl. details on Roles and Responsibilities and capabilities. Guides targets/objectives, provides development feedback and evaluates performance. Supports development and implements criteria for CRMA performance assessments. Identifies CRMA talents, and promotes further development incl. succession planning Promotes adherence/compliance to SOPs, the global training and on-boarding plans within the Cluster. May deputize for Regional Head CRMA. Ideal Background Education: Scientific degree: MD, PhD or PharmD to allow diverse CRMA team
(MDs preferable, depending on countries needs and availability)
Languages: Speaks and writes English Speaks at least local language of one country (if other than English) Experience: Skills:
Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex clinical / medical / operational issues. Agility to move fast across different therapeutic areas and indications Experience:
At least 6 years experience in pharmaceutical industry with at least 3 years experience in clinical development or trial monitoring across different indications / Therapeutic areas. Demonstrated leadership skills e.g. in a matrix with the ability to inspire teams and external experts. Sound understanding of the overall clinical development and ICH/GCP. Track record of delivering complex global clinical projects in quality and time . Demonstrates a knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial Applies a detailed understanding of the drug in question to provide medical/clinical context as it relates to disease processes, populations, and standards of care Ability to assess the feasibility of a clinical trial protocol based on cluster medical practice and sound understanding of the overall clinical development plan Demonstrating an understanding of regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials Providing medical/clinical expertise to facilitate the safe use of product(s) in clinical trials Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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